1. Regulation of Biopharmaceuticals in Canada Environmental Research ENVR 401 Supervisor George McCourt Oct. 16, 2003

2. Presentation Outline  Client background  Context of Research  Research Question  Methodology  Expected Results  Data Sources  Possible Problems

3. Group Members  Ashleigh Akalehiywot  April Aliermo  Mara Dacso  Lillian Harris  Andrea Hicks  Ted Walker  Kate Washington

4.  Regulation  Biopharmaceuticals  Environmental Risk

5. Polaris Institute ~ Ottawa, Canada  "enable citizen movements to re-skill and re-tool themselves to fight for democratic social change"  Challenges public policy making www.polarisinstitute.org

6. Biojustice Project ~ Lucy Sharratt  Concerned with the power of large corporations to push genetically engineered products and industries.  Aims to provide information and resources to grass-roots anti-biotech activists.

7. Biojustice Project – Our Role  To fill in the gaps within research and regulation of plant molecular farming (biopharmaceuticals)  To provide a framework on which the institute can use to influence regulation

8. Context of Research  1980’s advances in biotechnology  1990’s introduction of regulations  Regulatory Directive Dir2000-07: Guidelines for the Environmental Release of Plants with Novel Traits within Confined Field Trials in Canada

9. Context of Research  Three governing bodies:  Canadian Food Inspection Agency (CFIA)  Health Canada (HC)  Environment Canada (EC)  "used existing acts to incorporate new regulations or amend existing ones in order to deal with GM foods" (CBAC, 2002)

10. Context of Research  Royal Society of Canada Report Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada (2001)  Commissioned by CFIA, HC, and EC  53 recommendations

11. Context of Research  Government Response to RSC Report  Action Plans - November 23, 2001  4 updates since, most recent in June 2003

12. Context of Research  Interim Amendment to Dir2000-07 for Confined Research Field Trials of PNT's for Plant Molecular Farming April 22, 2003

13. Directives (Pre-2001) Interim Amendments (2003) RSC (2001) Action Plans (2001) Original Legislation (1980’s)

14. Research Question To what extent do the Interim Amendments on field testing of Plant Molecular Farming address the environmental concerns raised in the RSC report?

15. Research Question  Motivations for creating the amendments?  Time-line for solidifying the amendments as regulation?  Effectiveness of the amendments in addressing environmental risk?

16. Directives (Pre-2001) Interim Amendments (2003) RSC (2001) Action Plans (2001) Original Legislation (1980’s)

17. Methodology Extended Literature Review  Extensive analysis of government regulations, documents, conference papers  To determine sources of information and reasoning behind the amendments

18. Methodology Case Studies  Comparison between the European Union, the United States and Canada  Determine how each regulates Plant Molecular Farming  Compare effectiveness

19. Methodology Interviews  Interviews with government officials  To determine the progress of solidifying the amendments and phase currently underway

20. Methodology  Comparison of the amendments with scientific data and the RSC report  Determine the extent to which environmental risk is addressed in the amendments

21. Expected Results  Identify gaps in Canada's regulatory system  Provide Polaris Institute with a framework for further work with the government and the public concerning regulation

22. Data Sources  Primary sources (interview)  Published scientific research  Published reviews of current research and regulation (RSC report)  Government documents from Canada, US, and the EU

23. Time Line Weeks 1 & 2 establish baseline data for Canada & contact potential interviewees Week 3 begin case study research (EU &US) Week 4 compile/analyze/compare findings Week 5 design framework for final report Week 6 prepare for presentation Week 7 presentation & finish report

24. Division of Labour Administrative Tasks  Liaison with Lucy (Mara)  Liaison with Field Study Group (Lillian)  Research Paper editors (April, Kate)  PowerPoint presentation (Ted, Ashleigh)  Final Oral (Andrea, Kate)  Website (Ted, April)

25. Division of Labour Research Tasks  EU Case Study (Lillian, Kate)  US Case Study (Mara, Ashleigh)  Government contact interview (April)  RSC expert (Andrea)  Action Plan expert (Ted)  Canadian Regulation experts (everyone)

26. Possible Problems  Addressing client's needs  Focusing scope of research to a manageable area  Accessing sufficient information  Accessing relevant information

27. In a nutshell… Determine effectiveness of Canada's regulatory system for the field testing of biopharmaceuticals.